Analyst QA IIApply Now
Location: Plainsboro, New Jersey
Employment Type: Contract
Job Description
Contact Length: 1 year, hybrid role
Job Summary: This person will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.
Responsibilities:
Requirements:
Job Summary: This person will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.
Responsibilities:
- Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.
- Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21CFR Part 11 Compliance and other relevant regulations.
- Review, and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.
- Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
- Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.
Requirements:
- Education requirement, minimum: Bachelor’s degree in computer science, Information Technology, Life Sciences, or a related field
- Experience requirement, minimum: minimum of 4 years of direct experience in validation in pharmaceutical, biotechnology, or regulated healthcare industry
- Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21CFR Part 11 compliance.
- Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
- Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
- Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
Contact
Eric Carmody
Life Science Recruiting Manager
Back to Jobs Email to a Friend Apply Now